CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 90 target
Drug / intervention
Blinatumomab +3 morebiological
Likely dose
Not stated in record
Key inclusion· 10
  • ✓Ph-positive ALL (untreated or with ≤2 prior chemotherapy courses) or lymphoid accelerated/blast phase CML
  • ✓Relapsed/refractory Ph+ ALL or previously treated lymphoid accelerated/blast phase CML
  • ✓ALL MRD positive by NGS, PCR, or flowcytometry or previously treated lymphoid accelerated/blast phase CML
  • ✓Age ≥18 years
Key exclusion· 14
  • ✕Active serious infection not controlled by antibiotics
  • ✕History of acute pancreatitis within 1 year or chronic pancreatitis
  • ✕History of alcohol abuse
  • ✕Uncontrolled hypertriglyceridemia >650 mg/L

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03263572
NCT03263572Phase 2RecruitingOn Track
Long Recruiting
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Phase II Study of the Combination of Blinatumomab and Ponatinib in Patients With Philadelphia Chromosome (Ph)-Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia (ALL)

M.D. Anderson Cancer Center·interventional·Posted Aug 28, 2017·Updated May 20, 2026

In Brief

A Phase 2 clinical trial evaluating Blinatumomab, Cytarabine, and 2 other interventions for Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive and 7 related conditions. Currently recruiting, targeting 90 participants across 1 site.

Detailed Summary

This phase II trial studies how well blinatumomab, methotrexate, cytarabine, and ponatinib work in treating patients with Philadelphia chromosome (Ph)-positive, or BCR-ABL positive, or acute lymphoblastic leukemia that has come back or does not respond to treatment. Immunotherapy with monoclonal antibodies, such as blinatumomab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as methotrexate and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ponatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving blinatumomab, methotrexate, cytarabine, and ponatinib may work better in treating patients with acute lymphoblastic leukemia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAccelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Acute Lymphoblastic Leukemia, BCR-ABL1 Fusion Protein Expression, Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Philadelphia Chromosome Positive, Recurrent Acute Lymphoblastic Leukemia, Refractory Acute Lymphoblastic Leukemia, t(9;22)
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI), Amgen, Takeda

Timeline

Phase 2Recruiting
20182019202020212022202320242025202620272028
First PostedAug 28, 2017
Enrollment StartNov 29, 2017
Primary CompletionNov 30, 2027
TodayJul 1, 2026
Enrollment to primary: 10.0 yearsPosted 8.8 years agoPrimary completion in 1.4 years

Interventions

Blinatumomabbiological

Given IV

Cytarabinedrug

Given intrathecally via spinal tap

Methotrexatedrug

Given intrathecally via spinal tap

Ponatinibdrug

Given PO